FDA: Propylthiouracil (PTU)-Induced Liver Failure

FDA is notifying healthcare professionals of the risk of serious liver injury, including liver failure and death, with the use of propylthiouracil (PTU) in adult and pediatric patients. ...

EMEA: ICH Topic Q8, Q9 and Q10 Note for guidance on Pharmaceutical Development Quality Risk Management Pharmaceutical Quality System Questions and Answers

This Questions and Answers document (Q&A) refers to the current working procedure of the ICH Q-IWG on implementing the guidelines of Q8, Q9 and Q10 which have been approved by the ICH Steering ...

MHRA: Concept paper on MHRA project to consolidate and review medicines legislation - outcome published

The outcome of the concept paper which sought the input of stakeholders into the project on the review and consolidation of medicines legislation has now been published. ...

EDQM: EDQM establishes confidentiality agreements with US-FDA and TGA

The EDQM has established bilateral confidentiality agreements with the United States Food and Drug Administration (US-FDA) and the Australian Therapeutic Goods Administration (TGA) respectively to ...

MHRA: MHRA announces an exercise to update Summaries of Product Characteristics (SmPCs) to include paediatric information following completion of European work-sharing procedures

Inclusion of paediatric information in marketing authorisations following european work-sharing procedures ...

EMEA: Paediatric investigation plans (PIPs), waivers and modifications - Procedural Advice

This procedural advice addresses a number of questions which applicants may have before submitting an application. The information provided - under the form of Questions and Answers - will be ...

FDA: Providing Regulatory Submissions in Electronic Format--Drug Establishment Registration and Drug Listing

This guidance document is designed to assist industry (e.g., manufacturers, repackers, and relabelers) with the electronic submission of drug establishment registration and drug listing ...

FDA: Food Labeling: Health Claims; Calcium and Osteoporosis, and Calcium, Vitamin D, and Osteoporosis Small Entity Compliance Guide

On September 29, 2008, FDA published in the Federal Register a final rule (73 FR 56477, corrected at 73 FR 66754, November 12, 2008) that amended its regulations on the calcium and osteoporosis ...

European Commision: Pharmaceutical legislation aligned with the new regulatory procedure with scrutiny

Regulation (EC) No 219/2009 of the European Parliament and of the Council of 11 March 2009 adapting a number of instruments subject to the procedure referred to in Article 251 of the Treaty to ...

EMEA: Rules for the implementation of Regulation (EC) No 297/95 as amended on fees payable to the European Medicines Agency and other measures

The rules apply to: Scientific advice and protocol assistance Scientific services Extension of marketing authorisations Type II variations Annual fee Administration ...

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